Antibiotic Therapy in Erupted Tooth Extractions
Raktažodžiai
Santrauka
apibūdinimas
The main objective of this trial is to evaluate the efficacy of the antibiotic after tooth extraction in preventing infections and to evaluate the effect of probiotic in reducing the possible antibiotic side effects. In order to analyze the effect of the antibiotic in terms of patient's general discomfort, a tailored form was prepared (Appendix A). The local signs and symptoms to evaluate are swelling, pain (assessed by the Visual Analogic Scale), presence of abscess, fever, post-extraction dental alveolitis (dry socket) and presence of trismus assessed as maximal mouth opening variation (mm). In addition adverse post-extraction events will be evaluated as follows: chewing impairments (assessed by the Visual Analogic Scale), speaking impairments (assessed by the Visual Analogic Scale), daily oral hygiene maneuvers impairments (assessed by the Visual Analogic Scale) and daily activities alterations (days-off from job/study). Moreover, the patients will be provided with a painkiller's prescription and they are required to take note of the painkillers needed during the first 7 days, i.e. until the first time point recall. The prescribed painkillers will be Ibuprofen 600 mg or naproxen sodium 500mg for those patients who reported allergy to ibuprofen. Finally, it will be a researcher duty to ask the patients if they needed to assume painkillers beyond the 7th day. Since the post-surgical sequelae depend also on the difficulty of extraction, the Appendix A provides a table in which the surgeon can take note of the type of extraction.
Datos
Paskutinį kartą patikrinta: | 02/29/2020 |
Pirmasis pateikimas: | 08/13/2019 |
Numatytas registravimas pateiktas: | 09/05/2019 |
Pirmas paskelbtas: | 09/08/2019 |
Paskutinis atnaujinimas pateiktas: | 03/06/2020 |
Paskutinis atnaujinimas paskelbtas: | 03/10/2020 |
Faktinė studijų pradžios data: | 09/30/2016 |
Numatoma pirminio užbaigimo data: | 09/29/2018 |
Numatoma studijų užbaigimo data: | 01/29/2019 |
Būklė ar liga
Intervencija / gydymas
Drug: Amoxicillin Clavulanate
Dietary Supplement: tooth extraction and antibiotic treatment + dietary supplement
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Experimental: Tooth extraction and antibiotic treatment Tooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days | |
Experimental: tooth extraction and antibiotic treatment + dietary supplement Tooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days + Bifidobacterium longum and Lactoferrin twice a day for 6days | Dietary Supplement: tooth extraction and antibiotic treatment + dietary supplement |
No Intervention: Tooth extraction tooth extraction without antibiotics and/or Bifidobacterium longum and Lactoferrin |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 18 Years Į 18 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: - Patients who needed tooth extractions - Patients older than 18 years - Patients able to understand and to sign a consent form Exclusion Criteria: - General contraindications to oral surgery - Third molar or impacted tooth extractions - Patients treated or under treatment with immunosuppressive agents or patients immunocompromised - Patients treated or under therapy with amino-bisphosphonate and anti-angiogenetic intravenous medications - Patients who received head and neck irradiation treatments - Patients who were diagnosed with uncontrolled diabetes - Patients suffering from renal failure - Pregnancy and breastfeeding patients - Patients diagnosed with drug and alcohol addiction - Patients who suffer from psychiatric disorders - Patients diagnosed with allergy to penicillin and probiotic |
Rezultatas
Pirminės rezultatų priemonės
1. Rate of post-operative infection after tooth extractions [21 days]
2. Rate of post-operative alveolar osteitis after tooth extractions [21 days]
Antrinės rezultatų priemonės
1. gastrointestinal symptoms [21 days]